Peripheral Interfaces in Amputees for Sensorimotor Integration
NCT ID: NCT04430218
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2020-08-18
2032-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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iSens
3 months trial with the iSens system
iSens
The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.
State of the Art Prosthesis
3 months trial with their own prosthesis.
No interventions assigned to this group
Interventions
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iSens
The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.
Eligibility Criteria
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Inclusion Criteria
* Acquired upper limb amputation
* Unilateral or bilateral amputation, Above or below elbow
* At least 6 months since time of amputation
* Current user of a myoelectric prosthesis or prescribed to use one
* Viable target nerves in the upper extremity \*
* Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
Exclusion Criteria
* Uncontrolled diabetes
* Chronic skin ulcerations
* History of poor wound healing without specific cause
* History of uncontrolled infection without specific cause
* Active infection
* Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
* Inability to speak English
* Expectation that MRI will be required at any point for duration of study or while device is implanted.
* Arthritis in the area of implant
* Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
* Presence of auto immune diseases, or conditions requiring immunosuppression.
21 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Congressionally Directed Medical Research Programs
FED
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Dustin J. Tyler, PhD
Role: PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH
Locations
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Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Cady SR, Lambrecht JM, Dsouza KT, Dunning JL, Anderson JR, Malone KJ, Chepla KJ, Graczyk EL, Tyler DJ. First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication. J Neuroeng Rehabil. 2025 Apr 23;22(1):90. doi: 10.1186/s12984-025-01613-z.
Lambrecht JM, Cady SR, Peterson EJ, Dunning JL, Dinsmoor DA, Pape F, Graczyk EL, Tyler DJ. A distributed, high-channel-count, implanted bidirectional system for restoration of somatosensation and myoelectric control. J Neural Eng. 2024 Jun 21;21(3). doi: 10.1088/1741-2552/ad56c9.
Other Identifiers
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RX003355-01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HT94252510204
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1612632
Identifier Type: OTHER
Identifier Source: secondary_id
CDMRP-PR241366
Identifier Type: OTHER
Identifier Source: secondary_id
A3355-R
Identifier Type: -
Identifier Source: org_study_id
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